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NCT01390077 · ClinicalTrials.gov registry record · Phase 2
Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01390077 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 8 participants.
The verdict
NCT01390077, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Nitisinone is a potent inhibitor of the enzyme that catalyzes the formation of homogentisic acid, and should be an even more logical treatment for alkaptonuria than for tyrosinemia, for which it has been approved by the FDA.The objective of this research is to explore reported age related differences in toxicity of nitisinone and its pharmacokinetic underpinnings and to develop an optimal therapeutic requirement for a targeted population of presymptomatic patients. The additional effect of mixtures of amino acids excluding tyrosine will be explored to take advantage of protein synthesis to avoid elevations of tyrosine that would otherwise limit the optimal dosage of nitisinone. The study is designed to treat patients and find the optimal dosage of nitisinone to obtain maximal reduction in levels of homogentisic acid and maintain safe levels of tyrosine. The long term objective in the target population of pre-symptomatic patients is the prevention of the characteristic effects on joint cartilage and tendons.
Interventions
- DRUG Nitisinone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2011-01 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01390077
The ClinicalTrials.gov registry entry for NCT01390077 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nitisinone is the first listed.
NCT01390077 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01390077 about?
NCT01390077 is a clinical study titled "Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria". Nitisinone is a potent inhibitor of the enzyme that catalyzes the formation of homogentisic acid, and should be an even more logical treatment for alkaptonuria than for tyrosinemia, for which it has been approved by the FDA.The objective of this research is to explore reported age related difference...
What is the current status of trial NCT01390077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2011-01. Estimated completion is 2016-07.
What interventions are being tested in trial NCT01390077?
The interventions under investigation include: Nitisinone (DRUG).
Who is sponsoring clinical trial NCT01390077?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
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